Spartan Solder
by Williams Gold Refining Co., Inc. 510(k)
Active
510(k) K854738
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854738 | Date6 Mar 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EJH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3710
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Spartan Solder is a dental alloy, classified as a base metal, designed for joining and repairing dental restorations. It is intended for use in dental procedures requiring soldering of metal components, such as crowns, bridges, and orthodontic appliances, ensuring structural integrity and durability in oral environments.
This device is supplied as a reusable alloy and is regulated under FDA 510(k) clearance (K854738) as a Class II dental product under regulation number 872.3710. It is distributed by Williams Gold Refining Co., Inc., and is intended for use in dental settings. No specific sterility or MRI safety information is provided in the data.